By Jason Jegge, Quality and Regulatory Consultant, MWA Consulting, Inc.
In follow-up to the How to Transition to the EU MDR Webinar on March 30, 2023, we would like to detail some of the transition highlights and considerations for your attention.
First and foremost, your organization should have a medical device quality management system in place. It will need to be updated and designed for all countries of anticipated sale. This system will need to be ISO 13485:2016 compliant at the least, include MDR requirements, and if selling products outside of the EU it will need to comply with other regulatory requirements. For example, to also sell product in Australia, Brazil, Canada, Japan, and the USA the Medical Device Single Audit Program will need to be implemented into the quality management system.
Ensure comprehensive considerations of medical device regulations, guidelines, and standards. For example, if product design and development is included as part of your organizations scope, ISO 14971:2019+A11:2021 should be followed. Other ISO standards will need consideration such as ASTM, IEC, ISO 10993, etc.
Have a project manager familiar with the EU MDR requirements assigned. It is very important to have a staff member with medical device regulatory compliance experience be your lead project manager. This provides project focus, discipline, and momentum.
Have a technical documentation and conformity assessment procedure developed. EU MDR auditors are specifically looking for these process controls during their audits and Technical File or Design Dossier reviews. This also provides an organized approach to what your product files will need following a gap assessment, and how to ensure all compliance needs are satisfactorily met.
The EU MDR Annex IX contains the conformity assessment route typically chosen by manufacturers of a device. Chapter I describes the procedure for assessing the manufacturer’s quality management system, and Chapter II describes the procedure for assessing the product’s technical documentation.
Annex X is the conformity assessment route typically chosen by manufacturers who choose not to fulfil the quality management system requirements of Annex IX. The manufacturer provides the notified body with the technical documentation, clinical evidence and, as appropriate, samples of the device for testing.
Two alternative conformity assessment routes are contained in Annex XI. This is used by manufacturers to complement Annex X. According to Part A of the Annex, if the routine production of the device is to be performed under quality management system principles, the manufacturer may submit an application for the Notified Body to assess the production quality assurance system. Per Part B of the Annex, if the production of the device is more of a custom nature, the manufacturer may apply to the Notified Body to test and verify each produced device.
Annex XIII contains the alternative procedures which are to be followed by manufacturers of devices custom made for individual patients.
Spend adequate time to develop a thorough Literature Search, Clinical Evaluation and Post Market Surveillance system. These are becoming the largest bottlenecks for manufacturers as they are typically sparse in content compared to the desired results of Notified Bodies and what their training programs have asked of them during reviews. Lack of these as significant and robust submission documentation will cause additional rounds of reviews, and possible rejection of your MDR application, causing your organization to have to start all over again (and get back in the long line).
Create strong medical device regulatory compliance and medical device equivalence This has also caused many organizations quite the headache. Equivalency has undergone significant scrutiny from the Notified Bodies and needs to be carefully addressed, with robust documentation and justifications.
Create a plan with checklists for the project. Your project manager should create this plan to determine the appropriate resource load, timing of parent and child tasks to realistically determine the project needs and timelines.
About the Author
Jason Jegge is a principal consultant with MWA Consulting. He has worked in the medical device industry for over 30 years. Jason’s medical device industry experience has involved Class I, II, IIa, IIb and Class III, 510k, DeNovo, BLA, IND, NDA, PMA, implantable, diagnostic, and disposable devices. His product development experience includes early project strategy as well as project planning and execution for concept through commercialization stages, including clinical trials.